INSTRUCTIONS medical use drug

Registration number:

Trade name:

Piracetam

International nonproprietary name:

Piracetam

Dosage form:

tablets, coated film-coated

Composition per tablet:

Dosage 800 mg
Active substance:
piracetam - 800.0 mg.

croscarmellose sodium - 12.0 mg, pregelatinized starch - 12.0 mg, povidone (polyvinylpyrrolidone) - 20.0 mg, magnesium stearate - 8.0 mg.

hypromellose - 15.2 mg, macrogol-4000 - 4.0 mg, titanium dioxide - 8.8 mg.

Dosage 1200 mg
Active substance:
piracetam -1200.0 mg.

Excipients (core):
croscarmellose sodium - 18.0 mg, pregelatinized starch - 18.0 mg, povidone (polyvinylpyrrolidone) - 30.0 mg, magnesium stearate - 12.0 mg.

Excipients (shell):
hypromellose - 22.8 mg, macrogol-4000 - 6.0 mg, titanium dioxide - 13.2 mg.

Description:

Dosage 800 mg
Capsule-shaped tablets of biconvex shape, film-coated, white or almost white, with a risk on one side. Slight surface roughness is allowed. At the fracture, two layers are visible - a white or almost white core and a film shell.

Dosage 1200 mg
Oval, biconvex, film-coated tablets of white or almost white color, scored on one side. Slight surface roughness is allowed. At the fracture, two layers are visible - a white or almost white core and a film shell.

Pharmacotherapeutic group:

Nootropic drug.

ATX Code

N06BX03.

Pharmacological properties

Pharmacodynamics
The active ingredient is piracetam, a cyclic derivative gamma-aminobutyric acid(GABA).

Available evidence suggests that the primary mechanism of action of piracetam is not cell-specific or organ-specific.

Piracetam binds to the polar heads of phospholipids and forms mobile drug-phospholipid complexes. As a result, the two-layer structure is restored cell membrane and its stability, which in turn leads to the restoration of the three-dimensional structure of membrane and transmembrane proteins and restoration of their function.

At the neuronal level, piracetam facilitates various types synaptic transmission, having a predominant effect on the density and activity of postsynaptic receptors (data obtained from animal studies). Piracetam improves functions such as learning, memory, attention and consciousness without causing sedation or psychostimulant effects.

The hemorheological effects of piracetam are associated with its effect on red blood cells, platelets and the vascular wall.

In patients with sickle cell anemia, piracetam increases the ability of red blood cells to deform, reduces blood viscosity and prevents the formation of coin columns. In addition, it reduces platelet aggregation without significantly affecting platelet count.

Animal studies have shown that piracetam inhibits vasospasm and counteracts various vasospastic substances.

In studies on healthy volunteers, piracetam reduced the adhesion of red blood cells to the vascular endothelium and stimulated the production of prostacyclins by healthy endothelium.

Pharmacokinetics
Suction.
After oral administration, piracetam is quickly and almost completely absorbed from gastrointestinal tract. The bioavailability of piracetam is close to 100%. After a single dose of the drug in a dose of 3.2 g, the maximum concentration (C max) is 84 mcg/ml, after repeated doses of 3.2 mg 3 times a day - 115 mcg/ml and is achieved after 1 hour in the blood plasma and after 5 hours V cerebrospinal fluid. Eating reduces Cmax by 17% and increases the time to reach it (Tmax) to 1.5 hours. In women, when taking piracetam at a dose of 2.4 g, Cmax and area under the concentration-time curve (AUC) are 30% higher than in men.

Distribution.
The volume of distribution (Vd) is approximately 0.6 l/kg. Piracetam penetrates the blood-brain and placental barriers. In animal studies, it was found that piracetam selectively accumulates in the tissues of the cerebral cortex, mainly in the frontal, parietal and occipital lobes, in the cerebellum and basal ganglia.

Metabolism.
Does not bind to blood plasma proteins and is not metabolized in the body.

Excretion.
The half-life (T1/2) is 4-5 hours from blood plasma and 8.5 hours from cerebrospinal fluid. The half-life does not depend on the route of administration. 80-100% of piracetam is excreted unchanged by the kidneys by glomerular filtration. The total clearance of piracetam in healthy volunteers is 80-90 ml/min. T1/2 is prolonged in case of renal failure (in case of end-stage chronic renal failure - up to 59 hours). Pharmacokinetics
piracetam does not change in patients with liver failure.

Indications for use:

In adults

Symptomatic treatment psychoorganic syndrome, in particular in elderly patients, accompanied by memory loss, dizziness, reduced concentration attention and decreased activity, mood changes, behavior disorder, gait disturbance (these symptoms may be early signs age-related diseases such as Alzheimer's disease and senile dementia Alzheimer's type);
- Treatment of dizziness and associated imbalance, with the exception of vascular and psychogenic dizziness;
- Complex therapy and monotherapy for cortical myoclonus;

Treatment of dyslexia (in combination with other methods);
- Complex therapy of sickle cell anemia (for the prevention of sickle cell vaso-occlusive crisis).

Contraindications:

- Individual intolerance piracetam or pyrrolidone derivatives, as well as other components of the drug;
- Psychomotor agitation at the time of drug prescription;
- Huntington's chorea;
- Acute disorder cerebral circulation(hemorrhagic stroke);
- End-stage renal failure (with creatinine clearance less than 20 ml/min);
- Childhood up to 3 years.

With caution:
violation of hemostasis; extensive surgical interventions; heavy bleeding; chronic renal failure(with creatinine clearance 20-80 ml/min).

Use during pregnancy and lactation

Controlled studies The drug has not been used during pregnancy. Piracetam penetrates the placental barrier and into breast milk. The concentration of the drug in newborns reaches 70-90% of its concentration in the mother’s blood. Piracetam should not be prescribed during pregnancy. During lactation, the issue of stopping breastfeeding should be decided.

Directions for use and doses

Inside.

During meals or on an empty stomach, with liquid.

Symptomatic treatment of psychoorganic syndrome: 2.4 - 4.8 g/day in 2-3 doses.

Treatment of dizziness and associated imbalance: 2.4 - 4.8 g/day in 2-3 divided doses.

Treatment of cortical myoclonus: start with a dose of 7.2 g/day, every 3-4 days the dose is increased by 4.8 g/day until maximum dose 24 g/day in 2-3 doses. Treatment is continued throughout the entire period of the disease. Every 6 months, attempts should be made to reduce the dose or discontinue the drug, gradually reducing the dose by 1.2 g/day every 2 days.

Treatment of sickle cell anemia: daily prophylactic dose is 160 mg/kg body weight, divided into 4 equal doses.

Treatment of dyslexia in children (in combination with other treatment methods): recommended daily dose for children over 8 years old and adolescents - 3.2 g, divided into 2 doses.

Dosing in patients with impaired renal function: the dose should be adjusted depending on the value of creatinine clearance (CC):
Creatinine clearance for men can be calculated from serum creatinine concentration using the following formula:

For elderly patients, the dose is adjusted in the presence of renal failure, long-term therapy control needed functional state kidney

Dosing in patients with impaired liver function:
patients with impaired liver function do not need dose adjustment. For patients with impaired renal and liver function, dosing is carried out according to the scheme (see section “Dosing for patients with impaired renal function”).

Side effect

From the outside nervous system: motor disinhibition, irritability, drowsiness, depression, asthenia, headache, insomnia, agitation, imbalance, ataxia, exacerbation of epilepsy, anxiety, hallucinations, confusion.

From the outside digestive system: nausea, vomiting, diarrhea, abdominal pain (including gastralgia).

From the side of metabolism: increase in body weight.

From the hearing organs: vertigo.

From the outside skin: dermatitis, itching, urticaria.

Allergic reactions: angioedema, hypersensitivity, anaphylactic reactions.

Overdose

Symptoms: diarrhea mixed with blood, pain in the abdomen.

Treatment: in case of significant overdose, rinse the stomach or induce vomiting. Symptomatic therapy is recommended, which may include hemodialysis. There is no specific antidote. The effectiveness of hemodialysis for piracetam is 50-60%.

Interaction with other drugs

The possibility of changing the pharmacokinetics of piracetam under the influence of other drugs is low, because 90% of piracetam is excreted unchanged by the kidneys.

When used simultaneously with hormones thyroid gland Reports of confusion, irritability and sleep disturbances have been noted.

According to a published study in patients with recurrent venous thrombosis piracetam at a dose of 9.6 g/day increases effectiveness indirect anticoagulants(there was a more pronounced decrease in platelet aggregation, fibrinogen levels, von Willebrand factors, blood and plasma viscosity compared to the use of indirect anticoagulants only).

In vitro, piracetam does not inhibit cytochrome P450 isoenzymes, such as CYP1A2, 2B6, 2C8, 2C9, 2C19, 2B6, 2E1 and 4A9/11 at concentrations of 142, 426 and 1422 μg/ml. At a concentration of 1422 mcg/ml, a slight inhibition of CYP2A6 (21%) and ZA4/5 (11%) was noted, however, the Ki level of these two isoenzymes is sufficient when exceeding 1422 mcg/ml, and therefore metabolic interaction with other drugs is unlikely.

Taking piracetam at a dose of 20 g/day for 4 weeks did not change the maximum serum concentration and the area under the concentration-time curve of antiepileptic drugs (carbamazepine, phenytoin, phenobarbital, valproic acid).

Co-administration with alcohol did not affect serum concentrations of piracetam; The concentration of ethanol in the blood serum did not change when taking 1.6 g of piracetam.

Special instructions

When treating cortical myoclonus, abrupt interruption of treatment should be avoided, as this may cause resumption of attacks.
When treating sickle cell anemia, a dose of less than 160 mg/kg or irregular use of the drug may cause an exacerbation of the disease.
Penetrates through the filter membranes of hemodialysis machines.

Impact on the ability to drive vehicles and operate machinery

During the treatment period, caution should be exercised when driving vehicles and engaging in other potentially dangerous species activities requiring increased concentration attention and speed of psychomotor reactions.

Release form:

Film-coated tablets 800 mg and 1200 mg.
10, 20, 30 tablets in a blister pack made of polyvinyl chloride film and printed varnished aluminum foil.
10, 20, 30, 40, 50, 60, 80, 90, 100 or 120 tablets in polymer jars for medicines.
One can or 1, 2, 3, 4, 5, 6, 8, 9, 10 or 12 blister packs along with instructions for use are placed in a cardboard package (pack).

Storage conditions:

In a place protected from light at a temperature not exceeding 25 ° C.
Keep out of the reach of children.

Best before date:

3 years.
Do not use after expiration date.

Conditions for dispensing from pharmacies:

According to the recipe.

Manufacturer:

Ozon LLC
Legal address: 445351, Russia, Samara region, Zhigulevsk, st. Pesochnaya, 11.

Address of place of production (address for correspondence, including for receiving claims):

445351, Russia, Samara region, Zhigulevsk, st. Gidrostroiteley, 6.

Before taking this drug, patients try to find out why Piracetam is prescribed. This medicine is very common in medical practice. It is widely used in neurology and psychiatry. Considering the indications for use of this medicine, it should be in the medicine cabinet of almost every elderly person.

Piracetam - composition of the drug

This nootropic consists of the main active component and auxiliary ingredients. Depending on the form in which Piracetam is produced, the composition may vary slightly. Produce this drug in these forms:

• capsules;
• solution;
• pills.

Piracetam - injections

The injection solution is available in ampoules. Each of them contains 5 ml of the drug. Piracetam is sold in packages containing 10 ampoules. The injection solution is a colorless or slightly yellowish liquid. In addition to the main active ingredient, Piracetam in ampoules also contains excipients:

• sodium acetate;
• acetic acid;
• water.

Piracetam - tablets

Externally, these are large pills of white or yellowish color. In addition to the main component of the same name, Piracetam tablets have the following composition:

• talc;
• stearate;
• ethylcellulose;
• povidone and so on.

Piracetam - indications for use

This drug is prescribed for various problems with health. Piracetam has extensive indications. In neurological practice it is prescribed in the following cases:

• cerebrovascular accidents;
• pathologies leading to impaired emotions and decreased intelligence;
• vascular diseases, including hypertension;
• brain intoxication;
• coma;

This is why Piracetam is prescribed in psychiatry:

• therapy for organic damage brain;
• in case of poor tolerance to neuroleptics in order to prevent complications caused by them;
• treatment of schizophrenia and epilepsy;
• prescribed in complex therapy.

In drug treatment practice, Piracetam is used in the following cases:

• chronic alcoholism;
• poisoning with barbiturates or alcohol;
• drug and alcohol withdrawal;
• delirious state.

Assign this medication even for children. In pediatrics it is used for:

• brain damage from intrauterine infections;
• oligophrenia;
• delayed mental or mental development.

How to take Piracetam?

All appointments must be made by a doctor. Piracetam has a special use. Tablets or capsules should be taken before or during food consumption. The daily dose must be divided into several doses. To prevent sleep problems, take the drug before 17.00. If prescribed injection solution, injections are given intravenously or intramuscularly. Sometimes the drug is administered by drip.

The simultaneous use of this medicine with alcoholic drinks. A 12-hour interval must be maintained. If Piracetam is prescribed to relieve a hangover, before starting therapy, you need to prepare the patient’s body:

1. Restore water balance.
2. Use Aspirin to relieve headaches.
3. Cleanse the body of toxins (activated carbon is used for this).

Piracetam - dosage

This medicine is used according to the standard scheme:

1. Recommended daily dosage tablets and capsules for an adult is 1200 mg. This amount of the drug should be taken in 3 doses. If there is no expected result, the daily dosage is increased to 3200 mg. When improvement occurs, the amount of the drug is reduced to 400 mg. In some cases, therapy lasts several months, and sometimes six months, followed by a reduction in dosage. The drug cannot be stopped abruptly!
2. If Piracetam is prescribed to a child, the dosage is prescribed significantly less than for adults. Children from 1 to 5 years old can take 800 mg per day (divided into 4 doses). For older children, the daily dosage increases to 1200-1600 mg. The recommended duration of therapy is 3 weeks.
3. Piracetam is administered intravenously, starting with small doses (3-4 g). After 1-2 days daily norm increases to 5-6 g. If the dynamics are positive, the patient is prescribed Piracetam tablets. Maximum duration injection therapy is 10 days.

Piracetam - side effects

The drug is generally well tolerated by patients. However, piracetam causes side effects for some. The following negative reactions of the body may be observed:

• irritability;
• confusion;
• drowsiness or, on the contrary, insomnia;
• hallucinations;
• tremor;
• increased sexual activity;
• headaches;
• imbalance.

If Piracetam 400 is taken in large quantities, this can cause such adverse reactions:

• blood pressure decreases;
• dermatitis appears on the skin, accompanied by severe itching;
• there is a sharp weight gain;
• there is an exacerbation of pathologies of the cardiovascular system;
• Nausea with vomiting and diarrhea are observed.

Piracetam - contraindications for use

Although this drug is often prescribed in medical practice, there are a number of conditions in which the use of this medicine is prohibited. Piracetam has the following contraindications:

• after a recent hemorrhagic stroke;
• strong psychomotor agitation at the time of prescription of the drug;
• intolerance to one of the components present in the drug;
• Gintington's chorea;
• lactation period;
• children's age (up to 1 year).

Pregnancy is also included in the list of contraindications to the use of Piracetam. According to the manufacturers of this drug, the medication enters the baby’s body through the placenta and accumulates in its brain. In the future, this may lead to nervous disorder baby. However, in practice this drug is still used. It is prescribed in cases where the threat to the mother's health is significantly higher than the risk to the fetus.

In this article you can find instructions for use medicinal product Piracetam. Feedback from site visitors - consumers - is presented of this medicine, as well as the opinions of specialist doctors on the use of Piracetam in their practice. We kindly ask you to actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not stated by the manufacturer in the annotation. Analogs of Piracetam if available structural analogues. Use for treatment vascular disorders, Alzheimer's disease, epilepsy and blood pressure in adults, children (including newborns), as well as during pregnancy and lactation. Action of the drug.

What kind of medicine is this

In Russia and a number of other countries, the drug Piracetam is used in practice for the treatment of psychiatric, neurological and other diseases. Under the influence of the drug, ATP in the brain tissue increases and glycolytic processes are activated. According to studies, the drug improves brain function in case of oxygen starvation.

Drug group

Pharmacotherapeutic group: nootropic agent.

International generic name: piracetam

Trade name: Piracetam

Latin name: Piracetamum

Compound

The main component of the drug is piracetam, the amount contained in 1 tablet is 200 mg. Contents of other components:

• Copovidon.
• Polyethylene glycol.
• Hydroxypropyl cellulose.
• Titanium dioxide.
• Polydextrose.
• Iron oxide.
• Iron oxide is yellow and red.
• Medium-link triglycerides.

Mechanism of action and properties

Pharmacology

Pharmacological action - nootropic.

Main characteristics

Piracetam is a nootropic that acts directly on the brain, improving cognitive processes such as learning and mental performance, memory and concentration. The effect of the drug on the central nervous system is carried out in several ways: improving nerve cells metabolic processes, changing the speed of spread of excitation in the brain, improving microcirculation, does not cause vasodilator effect when affecting the rheological characteristics of blood.

In the brain, it improves blood flow and improves connections between the hemispheres. The medicine reduces the adhesion of red blood cells and restores their elasticity, blocks platelet aggregation.

Due to hypoxia, it restores impaired brain functions. Piracetam, according to experimental data, enhances the effects of antidepressants and, when used together, can increase their effectiveness. Also, according to the PASS study, the effectiveness of the drug in the treatment of acute ischemic stroke has not been proven.

Pharmacokinetics

The pharmacokinetic profile of the drug is linear and does not depend on time. 3 days after the start of administration, a constant concentration of the drug is achieved in the blood plasma.

How long does it take for the drug to start working? The effect occurs 30 minutes after the drug is absorbed from the digestive tract. Accumulation in brain tissue occurs after 4 hours. The same time is required for half-life from the body. It takes a little longer to be cleared from the cerebrospinal fluid, up to 8.5 hours. Not metabolized in the body.

What is it derived from?

90% of the drug is excreted unchanged by the kidneys. The half-life may be prolonged due to renal impairment. The kinetics of Piracetam does not change in patients with liver failure.

Effect on the kidneys. Since the drug is excreted by the kidneys, it is important to exercise caution during the course of therapy in patients with renal failure. In the case of the final stage, taking the drug is contraindicated. If you need to take medicine long term, monitoring of the functioning of the kidneys is necessary.

Effect on the liver. In patients with liver dysfunction, no dose adjustment is required.

Indications

What does Piracetam treat? Why do narcologists, neurologists and psychiatrists prescribe the drug?

According to the instructions, the drug can be prescribed in the following cases:

• dizziness, imbalance, headaches due to poor circulation;
• intoxication and hypoxia, concussion and trauma;
• poor memory, inattentiveness.

Not everyone knows what else Piracetam helps with. In addition to the above, the benefits of the drug were noted in the following cases:

• used in complex treatment drug addiction and alcoholism;
• in case of poisoning with sleeping pills;
• used for depression, apathy and other mental illnesses.

What else is Piracetam used for?

• for the treatment of epilepsy, Parkinson's disease and Alzheimer's disease;
• hypertension and atherosclerosis.

Release form

Most often prescribed dosage form- tablets 200 mg. However, the drug is also produced in other forms:

• capsules 400 mg;
• tablets 200 mg and 400 mg;
• injection solution 20% (1 g of piracetam in 1 ampoule for injections);
• granules for children for preparing a solution.

When asked what better than tablets or capsules, there is no exact answer. Both forms of the drug are absorbed through the digestive tract, but in this case the capsules dissolve faster.

Choosing between tablets and ampoules, if an intensive method of recovery is required brain activity, injections are preferred. In this way, the drug penetrates into tissues faster, bypassing the digestive tract.

Instructions for use

How to take or inject?

The tablets are intended for oral administration. Take whole, without chewing, with plenty of water. According to the approved annotation of the injection manufacturer, the medicine is administered intravenously or intramuscularly. In the first case, glucose or sodium chloride solution is used as a solvent.

The dosage for adults when taking tablets is 30-160 mg per 1 kg of body weight 2-4 times a day. Dosage for children is within 30-50 mg per 1 kg of body weight 2-3 times a day. The minimum course of therapy is 3 weeks. If necessary, the doctor can adjust the dosage and period of use of the drug. The maximum daily dose for children is 1800 mg.

The dosage for injections is:

• psychoorganic syndrome - 2-4 g per day, it is possible to increase the dose to 6 g. Treatment is prescribed for up to 15 days;
• after a stroke - 4.8 g per day for up to 15 days;
• alcohol withdrawal syndrome - 2.4 g per day for up to 15 days;
• sickle cell anemia - 160 mg/kg, in crisis - 300 mg/kg intravenously. The same dosage is acceptable for children after 1 year.

Side effect

Possible negative reactions to Piracetam:

• CNS: dizziness, imbalance, insomnia, headache;
• psyche: depression, anxiety, nervousness, hallucinations;
• immunity: increased sensitivity to the drug, anaphylaxis;
• digestive tract: digestive disorders, vomiting, nausea, stomach pain;
• skin: dermatitis, rashes, itching, urticaria;
• blood: clotting disorder.

Other adverse reactions may include weight gain, increased blood pressure, excessive sweating. Injectable forms can cause a decrease in blood pressure and an increase in body temperature.

Contraindications

Treatment with the drug is prohibited if:

• hypersensitivity to piracetam or pyrrolidone;
• psychomotor agitation;
• Huntington's disease;
• children under 3 years of age;
• hemorrhagic stroke;
• renal failure (end stage).

Use in children

Children may already be prescribed this drug from birth. It can be included in the complex treatment of postpartum injuries and hypoxia. Use is also justified for enuresis, mental retardation, cerebral hydrocele, and developmental delays.

What does the drug help older children with? Mostly children over 5 years of age take medicine for attention deficit disorder and dyslexia. Helps children increase the speed of assimilation of information during the learning process.

Use during pregnancy and breastfeeding

Penetration active substance occurs through the placental barrier. In newborns, plasma concentration reaches 70-90% of that in the mother. During pregnancy, you should avoid taking Piracetam.

The active substance passes through breast milk. The drug is contraindicated during breastfeeding; otherwise, the feeding process should be interrupted.

Use in the elderly

The drug can be prescribed to pensioners as a prophylaxis for many diseases, with senile psychosis and dementia, in treatment coronary disease reduces the need for nitroglycerin.

Driving a car and other mechanisms

At the time of taking the drug, you should be careful when driving vehicles and engaging in other activities that require increased attention.

Do I need a prescription?

The drug is dispensed from pharmacies with a doctor's prescription.

Compatibility with other drugs

Piracetam is often prescribed in complex treatment. At drug interactions with antidepressants, psychostimulants and cardiac drugs, Piracetam enhances their effect.

It is not recommended to use the drug and thyroid hormones together, as adverse reactions are possible. In the complex treatment of epilepsy, withdrawal anticonvulsants contraindicated because Piracetam can lower the threshold for seizure activity.

Alcohol compatibility

Alcohol in itself is harmful, and in case of illness it is completely contraindicated. The consequences of taking the drug and alcohol are unpredictable. Ethyl can both enhance the effect of the drug and reduce its therapeutic effect.

Some people are wondering if Piracetam and alcohol are compatible. Although the drug may be prescribed for withdrawal syndrome, it is not compatible with alcohol. You can start taking the medicine 10-12 hours after drinking alcohol.

Analogues of the drug Piracetam

Structural analogues of the active substance:

• Lutsetam;
• Memotropil;
• Nootobril;
• Nootropil;
• Noocetam;
• Pirabene;
• Pyramem;
• Pyratropil;
• Piracetam Bufus;
• Piracetam MS;
• Piracetam Obolenskoe;
• Piracetam Vial;
• Piracetam Ratiopharm;
• Piracetam Richter;
• Piracetam Eskom;
• Stamin;
• Cerebril;
• Escotropile.

If there are no analogues of the drug for the active substance, you can follow the links below to the diseases for which the corresponding drug helps, and look at the available analogues for the therapeutic effect.

Piracetam - nootropic drug, which has a positive effect on metabolic processes and blood circulation in the brain. The uniqueness of nootropics is that of all neurotropic drugs only they can be used for both treatment and prevention. The scope of their application is very wide and extends far beyond the boundaries of any single nosology. Thus, nootropics are regulators of natural metabolic processes in the central nervous system, ensuring their unhindered flow under conditions of various stresses, as well as during aging of the body, when the brain becomes susceptible to vascular lesions, Parkinson's disease, dementia, etc. The “pioneer” among nootropics is piracetam. Despite this, the drug is still the most popular nootropic drug, filling more than half of the total nootropic market. The biography of piracetam as a drug dates back to 1963. However, its main advantage - the ability to improve memory and assimilation of information - was discovered much later, in 1972. Piracetam has a number of the most important characteristics. Thus, it increases the utilization of glucose by tissues, facilitates metabolic processes, stimulates blood circulation in ischemic areas, and suppresses platelet aggregation (sticking together). Piracetam has a protective effect on the brain when various kinds damage: hypoxia, toxic or electrical shock. Improves cognitive functions without having a psychostimulating or sedative effect. Among the advantages of piracetam are the lack of binding to blood plasma proteins and non-metabolism, which makes its use more predictable and significantly reduces the risk of developing unwanted side effects. Piracetam can be successfully combined with various drugs pharmacological groups. Side effects when using piracetam are extremely rare and occur mainly in elderly patients initial stage treatment, as well as when the doses recommended by the instructions are exceeded.

When taken orally, the drug is quickly and completely absorbed into the digestive tract. Maximum concentration active substance in blood plasma is achieved on average after half an hour. The half-life of piracetam is 4-5 hours. The drug is excreted unchanged in the urine. In persons suffering from insufficient renal function, the half-life of piracetam increases, which must be taken into account when determining the therapeutic dose.

Piracetam is available in the form of tablets, capsules and solution for intravenous and intramuscular injection. The dose is calculated based on the patient's body weight. For adults, the daily dose is 30-160 mg per 1 kg in 2-4 doses. The duration of the medication course is 1.5-2 months. Depending on the clinical situation, piracetam can be prescribed in injection form at an initial dose of 10 g per day. At intravenous administration patients in in serious condition, the dose can be increased to 12 g. As the clinical situation improves, the dose is progressively reduced and the patient is transferred to piracetam capsules or tablets. Children are prescribed the drug in a daily dose of 30-50 mg per 1 kg of body weight in 2-3 doses. The duration of pharmacotherapy is at least 3 weeks. Taking piracetam by patients with serious hemostasis disorders, heavy bleeding who have undergone major surgical interventions, as well as those suffering from renal failure, should be carried out with extreme caution. In case of somnological disorders evening reception It is recommended to discontinue the drug by proportionally increasing its daily dose. When combining piracetam with thyroid hormones, central effects may develop - anxiety, irritability, tremor, confusion. When combining the drug with central nervous system stimulants, potentiation is possible psychostimulating effect. The combination of piracetam with antipsychotics causes increased extrapyramidal disorders.

Pharmacology

Nootropic drug. Renders positive influence on metabolic processes and cerebral circulation. Increases glucose utilization, improves flow metabolic processes, improves microcirculation in ischemic areas, inhibits the aggregation of activated platelets. It has a protective effect against brain damage caused by hypoxia, intoxication, and electric shock. Improves integrative brain activity. Does not have a sedative or psychostimulating effect.

Pharmacokinetics

When taken orally, it is quickly and almost completely absorbed from the gastrointestinal tract. Cmax in plasma is reached after approximately 30 minutes, in cerebrospinal fluid - after 2-8 hours. Apparent Vd is 0.6 l/kg. Does not bind to blood plasma proteins.

Distributed in all organs and tissues, penetrates the BBB and the placental barrier. Selectively accumulates in the tissues of the cerebral cortex, mainly in the frontal, parietal and occipital lobes, in the cerebellum and basal ganglia.

T1/2 from plasma is 4-5 hours, from cerebrospinal fluid - 6-8 hours. It is excreted unchanged by the kidneys. With renal failure, T1/2 increases.

Release form

10 pcs. - contour cell packaging (6) - cardboard packs
60 pcs. - polymer jars (1) - cardboard packs.

Dosage

Adults orally - 30-160 mg/kg/day in 2-4 doses. Duration of treatment is 6-8 weeks.

If necessary, apply intramuscularly or intravenously at an initial dose of 10 g/day. When administered intravenously to patients in severe condition, the daily dose can be 12 g. After clinical improvement, the dose is gradually reduced and switched to oral administration.

Children orally - 30-50 mg/kg/day in 2-3 doses. Treatment should be continued for at least 3 weeks.

Interaction

A case of interaction of piracetam with simultaneous use with a thyroid extract containing triiodothyronine and tetraiodothyronine has been described, when the patient had anxiety, irritability and sleep disorders.

When used simultaneously with thyroid hormone medications, the development of central effects- tremor, anxiety, irritability, sleep disturbances, confusion.

With the simultaneous use of central nervous system stimulants, the psychostimulating effect may be enhanced.

When used simultaneously with antipsychotics, an increase in extrapyramidal disorders is observed.

Side effects

From the digestive system: rarely - dyspeptic symptoms, abdominal pain.

From the side of the central nervous system: rarely - nervousness, agitation, irritability, anxiety, sleep disorders, dizziness, headache, tremor; in some cases - weakness, drowsiness.

Other: increased sexual activity.

Indications

Memory impairment, dizziness, decreased concentration, emotional lability, dementia due to cerebrovascular accidents (ischemic stroke), brain injury, Alzheimer's disease, in old age; comatose states vascular, traumatic or toxic origin; treatment of abstinence and psychoorganic syndrome in chronic alcoholism; learning disabilities in children not associated with inadequate training or characteristics of the family environment (as part of combination therapy); sickle cell anemia (as part of combination therapy).

Contraindications

Hemorrhagic stroke, severe renal failure (with CC<20 мл/мин), повышенная чувствительность к пирацетаму.

Features of application

Use during pregnancy and breastfeeding

Adequate and strictly controlled studies of the safety of piracetam during pregnancy have not been conducted. Use is possible only in cases where the expected benefit to the mother outweighs the possible risk to the fetus.

Piracetam appears to pass into breast milk. If it is necessary to use it during lactation, the issue of stopping breastfeeding should be decided.

Experimental studies on animals did not reveal any negative effects of piracetam on the fetus.

Use for renal impairment

Contraindicated in severe renal failure (with CC<20 мл/мин).

Use with caution in patients with renal failure. Continuous monitoring of renal function indicators is recommended.

Special instructions

Use with caution in patients with severe hemostatic impairment, during major surgical operations and severe bleeding; with renal failure.

Piracetam (lat. Pyracetamum) is a drug from the group of nootropics. Has a positive effect on brain functions and metabolic processes.

Stimulates mental activity, improves memory and learning ability, and increases the body's energy potential.

Currently, the scope of application includes pediatrics, internal medicine, addiction medicine, neurology and psychiatry. In total, more than 100 single-dose piracetam products are produced by various companies around the world.

Piracetam was first obtained in 1963 by Cornelia Giurgea, a biochemist at the Belgian pharmaceutical company USB Pharma. Initially, the remedy was intended to be used to treat seasickness. However, during research, additional therapeutic properties were discovered in the new substance.

It turned out that piracetam affects the body like psychostimulants. In experiments with volunteers, the drug improved cognitive abilities, memory and increased learning ability. However, he did not exhibit any adverse reactions typical of psychotropic medications.

By 1972, about 700 articles on the effects of piracetam had been published in scientific journals. In the same year, C. Giurgea introduced the concept of nootropics into pharmacology (translated from Latin noos - “thinking” and tropos - “affinity”). This term began to denote all non-narcotic drugs that can have a direct stimulating effect on mental abilities.

At the end of 1972, USB began producing the world's first drug, piracetam. The medicine was released under the brand name “Nootropil” and has found wide use in the treatment of diseases of the central nervous system, asthenic conditions and mental retardation in children.

After the expiration of patent protection, numerous generics of Nootropil began to enter the pharmaceutical market. Most copies have the trade name Piracetam, although there are also brand names (for example, in India - Maxitam, in Germany - Cerepar, in Hungary - Lucetam).

In search of new nootropics, scientists from different countries modified the formula of the drug. As a result, about 1.5 thousand new compounds were obtained, of which only 10 began to be used in medical practice (levetiracetam, oxiracetam, phenylpiracetam, etc.). Due to the similarity in chemical structure, the group was called "racetams".

Nootropic activity was also found in a number of other drugs: acephen, pyriditol, cerebrolysin, sodium hydroxybutyrate, etc.

Properties

International non-proprietary name: piracetam.

Chemical name: 1-carbamoylmethyl-2-pyrrolidone.

Structural formula:

Gross formula: C₆H₁₀N₂O₂

Molecular weight: 142,16.

Piracetam is a white or slightly yellowish crystalline powder. It dissolves well in water, less so in ethyl alcohol. Melting point - 151-155ºС. The chemical structure of the substance is similar to gamma-aminobutyric acid (GABA), which is a natural bioregulator of nervous activity.

Clinical data

Since 1972, 330 clinical studies have been conducted in different countries, the purpose of which was to confirm the effectiveness and safety of piracetam.

Tests in the 70-80s proved that the drug promotes memory consolidation, improves the assimilation of new information, and restores impaired brain functions.

The use of piracetam in children with mental retardation led to an acceleration of their rate of development. For patients who had suffered a stroke, the drug helped restore lost speech abilities.

In the early 90s, with the development of the ideas of evidence-based medicine, the results of many past studies began to be questioned, since the methods that were used in the process of conducting them could lead to distortion of the results.

At the same time, a rating system for evaluating clinical trials was introduced into world practice. New standards have appeared that describe the procedure for their implementation (including the international GCP standard).

In 1994, the first clinical trial of piracetam was conducted (Enderby et al.), which fully met the changed regulatory requirements. 158 patients with ischemic stroke took part in it, 67 of whom suffered from speech disorder (aphasia).

To assess the effectiveness of the drug, perception tests and functional activity tests were used. After 3 months of therapy, patients with aphasia showed a significant improvement in speech functions. No effect of piracetam on other neurological parameters was noted.

In the 1997 European multicenter study (PASS I, De Deyn P.P. et al), piracetam was prescribed to 927 patients with ischemic stroke. Patients of the first group were administered the drug within the first 6 hours after the attack, patients of the second group - after 6 or more hours.

The results showed that the use of the drug at an early stage of the ischemic cascade can accelerate the process of restoration of lost neurological functions.

In 2000, the effectiveness of piracetam was evaluated in a double-blind, placebo-controlled study (Class I study, Kessler et al.). It has been proven that the drug normalizes the exchange of information between the hemispheres of the brain and significantly improves impaired speech abilities.

A similar 2004 trial (Bakheit) found that piracetam treatment was only effective in acute post-stroke aphasia and was ineffective in patients with chronic aphasia.

In 2001, the Cochrane Society* conducted a pooled analysis of 52 clinical trials of piracetam. The results of 51 experiments were excluded from the sample due to their insufficient quality.

As a result, experts recognized only one test as reliable, which was examined in detail.

*The Cochrane Society is an international independent organization that studies the effectiveness and safety of medicines from the perspective of evidence-based medicine. The membership includes more than 30 thousand scientists from 130 countries. Reviews and community analyzes are archived in the public Cochrane Library. The organization officially cooperates with WHO.

Application in different countries

Piracetam drugs are used in more than 50 countries, including the UK, Japan, Germany, France, Russia and China. The medicines were registered and approved for sale by local health institutions. In all countries, piracetam is available with a prescription.

In the United States, the FDA (Food and Drug Administration) refused to register piracetam as a drug due to its insufficiently proven effectiveness in controlled studies.

Despite this, the product has long been part of food additives produced in the United States, the use of which, according to current legislation, does not require clinical trials. In the descriptions of the drugs, the nootropic was stated as “a component that improves brain and physical activity.”

In August 2010, the FDA sent a formal letter to US pharmaceutical manufacturers and distributors demanding that they stop producing and selling piracetam supplements because the active ingredient is not a naturally occurring food component but is synthetically produced. By the beginning of 2011, dietary supplements were discontinued.

Release forms

Piracetam is available in the form:

• 20% solution for intravenous and intramuscular injections,
• capsules containing the active substance 200, 400, 800 or 1200 mg,
• enteric-coated tablets containing 200, 400, 800 or 1200 mg of active substance,
• 20% syrup for children,
• 20% solution for oral administration.

Mechanism of action

Piracetam acts directly on the brain, stimulating mental activity and improving cognitive abilities. The drug affects the central nervous system in various ways:

• activates protein synthetic processes,
• increases the resistance of neurons to the action of free radicals,
• accelerates the transmission of excitation along nerve fibers,
• improves microcirculation without causing vasodilation.

In addition, piracetam has a number of vascular effects. The drug reduces platelet aggregation, weakens the degree of their adhesion to vascular walls, and reduces blood viscosity. At a dose of more than 960 mg per day, piracetam reduces fibrinogen levels and increases bleeding time by 30-40%.

In cases of brain dysfunction caused by hypoxia or intoxication, the drug has a restorative effect:

• improves concentration and memory,
• helps eliminate cognitive disorders.

On the electroencephalogram, the effects appear as increased alpha and beta activity.

The effect of piracetam becomes noticeable a few weeks after the start of therapy.

Metabolism and excretion

When taken orally, the drug is well and almost completely absorbed from the digestive tract: up to 95% of the dose taken enters the bloodstream.

When administered intramuscularly, the maximum concentration of piracetam in the blood is achieved after 30 minutes, in the cerebrospinal fluid - after 5 hours.

The drug penetrates the blood-brain and placental barrier. In experiments with animals, piracetam showed the ability to accumulate in the cerebral cortex.

The drug does not undergo metabolic transformations and is excreted unchanged from the body through renal filtration. The half-life from cerebrospinal fluid is 8.5 hours, from blood plasma - 5 hours.

Indications for use

The drug is used in therapy:

• consequences of a stroke,
• chronic alcoholism,
• vascular diseases of the brain,
• cortical myoclonus,
• comatose states,
• neuromuscular dystrophy,
• Parkinson's disease,
• Alzheimer's disease and other neurological diseases that are accompanied by a decrease in intellectual abilities,
• depressive and lethargic states,
• consequences of perinatal brain damage,
• oligophrenia,
• cerebral palsy,
• sickle cell anemia.

For practically healthy people, piracetam can be recommended when overworked or in extreme situations.

Contraindications

The drug is contraindicated:

• in case of individual intolerance,
• in the acute stage of hemorrhagic stroke,
• children under 1 year of age (tablets and capsules for children under 3 years of age),
• patients with severe renal failure (with CC<20 мл/мин),
• patients with Huntington's syndrome.

Pregnancy and breastfeeding

The effect of piracetam on the fetus has not been studied enough, so the drug is not recommended for use during pregnancy. When using the product during lactation, it is recommended to avoid breastfeeding.

Impact on the ability to operate transport and complex mechanisms

During the treatment period, caution should be exercised when driving and engaging in hazardous activities.

Directions for use and doses

The drug is prescribed orally, intramuscularly or intravenously.

For parenteral forms, the average dose is 2-4 g/day. The recommended course of therapy is 10-15 days. When treating the consequences of a stroke, the initial dose is 4.8 g/day, for comatose states - 9-12 g/day, for withdrawal syndrome - 12 g/day. The drug is discontinued gradually, moving after clinical improvement to maintenance doses of 2-2.4 g/day.

Enteral forms are taken with food or on an empty stomach with a small amount of liquid. The average daily dose for adults is 30-160 mg per 1 kg of weight, for children - 30-50 mg per 1 kg of weight. The daily amount of the drug is divided into 2-4 doses. Therapy is continued for at least 3 weeks.

Side effects

Negative reactions when taking piracetam are observed quite rarely (less than 1% of patients). Disorders of the nervous system are observed mainly in mental patients.

Possible side effects include:

• irritability,
• depression,
• insomnia or drowsiness,
• increased mental arousal,
• increased libido,
• dizziness,
• headache,
• shiver,
• imbalances,
• dyspeptic disorders (nausea, vomiting, abdominal pain),
• dermatitis,
• itchy rashes,
• angioedema.

Overdose

During the entire period of use of the drug, isolated cases of poisoning were recorded, which were manifested by acute diarrhea and pain in the abdominal area. The violations were caused by a single dose of piracetam in an amount of more than 75 g.

If an overdose occurs, gastric lavage and symptomatic therapy are performed.

Special instructions

Due to the effect of piracetam on the rheological characteristics of the blood, caution should be exercised when prescribing it to patients with hemorrhagic disorders, recently operated patients and people at high risk of bleeding.

Since the drug is excreted through the kidneys, patients with renal failure are advised to take it under strict medical supervision.

Elderly patients require regular monitoring of kidney function indicators and dose adjustment based on test results.

When treating cortical myoclonus, one should be wary of abrupt drug withdrawal, as this may lead to resumption of attacks.

Interaction with other drugs

While taking piracetam, the effectiveness of anticoagulants, antipsychotics and psychostimulants increases. With simultaneous therapy with thyroid drugs, patients experience irritability, confusion, and sleep disturbances.

It has been reliably established that the drug does not interact with phenobarbital, clonazepam, sodium valproate, ethanol.

Vacation conditions

According to the recipe.

Storage

In a dry place, protected from light, at a temperature not exceeding 20, 25 or 30ºС (depending on the dosage form and manufacturer).

Best before date

4-5 years (depending on the manufacturer).

Brief overview of manufacturers

More than 100 monomedicines of piracetam are produced worldwide. Medicines differ from each other in production technologies, auxiliary components and the amount of impurities.

Due to differences in manufacturing processes, minor differences in bioavailability, severity of therapeutic effects, and incidence of adverse reactions may occur between products from different manufacturers.

Some manufacturers of piracetam drugs:

Trade name of the drug	Manufacturer	Countries where use is permitted
Nootropil	USB Pharma (Belgium)	Austria, Belgium, Brazil, Czech Republic, Estonia, Germany, Finland, Russia, etc.
Memotropil	Polpharma (Poland)	Poland, Latvia
Normabrain	Torrent (India), USB Pharma (subsidiary, Germany)	India, Taiwan, Philippines, Germany
Piracebral	Hexal (Germany)	Germany, Bulgaria, Luxembourg
Lutsetam	Egis (Hungary)	Russia, Poland, Slovakia, Latvia, Georgia, Hungary, Romania, Bangladesh
Piracetam	Changzheng-Xinkai (China), AbZ-Pharma (Germany), Aliud (Czech Republic), Hemopharm (Bulgaria), Biogaran (France), DHG Pharma (Vietnam), Akrikhin (Russia), Sintez (Russia), Dalkhimpharm (Russia), FP Obolenskoe (Russia), Vertex (Russia), Irbitsky Chemical Plant (Russia), Borisov Pharmaceutical Plant (Republic of Belarus), Belmedpreparaty (Republic of Belarus), Farmak (Ukraine) and others.	Different countries

Analogs

All other nootropic drugs are analogues of piracetam. Their action is also aimed at activating higher mental functions and improving metabolic processes in the brain. However, in terms of effectiveness and safety, piracetam remains the reference drug for the entire class.

At the moment, this is the only nootropic that, due to its low toxicity and wide spectrum of action, belongs to the category of “smart drugs”.

For some piracetam analogues, improvement of mental activity is the leading therapeutic effect. Such drugs are called “true nootropics.” Other agents may have additional sedative, anticonvulsant or antihypoxic effects.

Different drugs differ from each other in terms of pharmacodynamics, side effects and contraindications.

Comparative characteristics of piracetam and some of its analogues:

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Trade name	Active substance	Manufacturer	Prevailing therapeutic effects	Adverse reactions	Contraindications
Piracetam	Piracetam	Companies from Russia, Ukraine, China, India, etc.	Improves mental activity, restores brain function	Insomnia or drowsiness, nervousness, dizziness, dyspepsia	Renal failure, age under 1 year, pregnancy, lactation, hemorrhagic stroke, Huntington's chorea
Aminalon	Gamma-aminobutyric acid	Organics (Russia), Shchelkovo Vitamin Plant (Russia), Akrikhin (Russia), Borisov Pharmaceutical Plant (Republic of Belarus), etc.	Improves memory and productivity of thinking. Has a moderate anticonvulsant effect	Sleep disturbances, nausea, fever, shortness of breath, changes in blood pressure	Hypersensitivity
Pantogam	Hopantenic acid	Peak-Pharma (Russia)	Stimulates metabolic processes in brain tissue. Has an anticonvulsant effect.	Allergic reactions, noise in the head, sleep disturbances	Pregnancy, lactation, renal dysfunction
Fezam	Piracetam and cinnarizine	Balkanfarma (Bulgaria)	It has a nootropic, antihypoxic and vasodilating effect. Reduces blood viscosity. Has a weak antiallergic effect.	Sleep disorders, headache, dyspeptic disorders	Age up to 5 years, individual intolerance, pregnancy, breastfeeding, renal or liver failure
Picamilon	Nicotinoyl gamma aminomas chloric acid	Akrikhin (Russia), Pharmstandard (Russia), Novosibkhimpharm (Russia), etc.